Transcranial Photobiomodulation (tPBM) in Alzheimer's Disease Study

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Aug 28, 2026 → Nov 28, 2027
See other at-risk trials from Cedars-Sinai Medical Center

Record History

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  1. Notable Primary completion pushed from Aug 28, 2026 to Nov 28, 2027 Show 5 more changesShow less
    • Start date changed from estimate of Dec 25, 2025 to Sep 1, 2026
    • Study completion pushed from Oct 2026 to Mar 30, 2028
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 5 of 6 entries
    • Publications: details revised at 7 of 7 entries
  2. Notable Start date: Oct 25, 2025 to Dec 25, 2025
    • Primary completion date: May 28, 2026 to Aug 28, 2026
    • Study completion date: Sep 2026 to Oct 2026
    • Secondary endpoints: 1 to 6
    v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The purpose of this study is to see if a special light treatment, called photobiomodulation, can help people with memory problems such as Mild Cognitive Impairment or Mild Dementia due to Alzheimer's disease. The light is given to the forehead using an FDA-cleared medical device. This device is cleared to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue. This device is being used "off-label," meaning it will be used in a way that is different than its cleared use. We want to learn whether this light treatment can improve executive function, and whether it changes certain inflammatory and neurodegeneration related signals in the blood. To do this, we will apply the photobiomodulation device to your forehead. We will also ask you questions and give you cognitive tests before and after light treatment. We will also collect blood samples before and after treatment.
Trial Details
NCT Number NCT07224607
Lead Sponsor Cedars-Sinai Medical Center
Conditions
(from sponsor)
Alzheimer's Disease
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov